BRIEFS
A Quarterly Update from the BWH Biomedical Research Institute (BRI)
Spring 2010 Issue
BWH Begins Recruitment for Historic, Nationwide Vitamin D Trial
Vitamin D and omega-3 are now in
the spotlight to be examined for their
disease prevention abilities. Americans, especially African-Americans,
are not getting enough of these nutrients, which are derived from sunlight,
supplements, fish and fortified foods
such as milk. This is a growing public
health concern, as some research suggests that vitamin D and omega-3 may
help prevent chronic conditions such
as cancer and heart disease.
But according to Dr. JoAnn Manson,
chief of Preventive Medicine at BWH,
more research on vitamin D and omega-3 needs to be done before definitive
conclusions can be drawn about the
protective effects of these nutrients. For
this reason, she is directing the largest
ever clinical trial seeking to investigate
whether diseases such as cancer, heart
disease, diabetes, depression and autoimmune disorders can be prevented
by taking a moderate to high dose of
vitamin D and omega-3. Positive findings could mean a low-cost option for
reducing the public health burden of
these conditions worldwide.
Dr. Manson’s five-year, $22 million
VITamin D and omegA-3 triaL, or the
VITAL trial for short, is sponsored
by the National Institutes of Health
and involves BWH, Harvard Medical
School and other prominent research
institutes. The study, which started recruiting in January, will enroll 20,000
participants nationwide. Men (60 and
older) and women (65 and older) without a history of cancer, heart disease,
or stroke are eligible. Participants will
be divided into treatment and control
groups and will be routinely monitored during the trial period.
Twenty-five percent of trial participants will be African-American, as certain diseases such as diabetes occur at
a greater rate in this population and
might be related to the vitamin D deficiency observed in these individuals.
“We hope that vitamin D supplementation may be able to reduce the health
gap related to race and ethnicity,” says
Dr. Manson.
To learn more or to see if you are eligible to participate, call 1-800-388-3963,
or visit www.vitalstudy.org.
(Top left) Dr. Manson explains how a pill calendar-pack works, similar to
the vitamin D and omega-3 supplement packs participants receive who are
part of the new VITAL trial at BWH.
BWH Investigators Strive to Eliminate Vitamin D Deficiency in Mongolia
Nomadic herders have lived on the Mongolian grass-covered plain for centuries in yurts, which
are portable, felt-covered, wood lattice-framed structures. Nearly 50 percent of the current
Mongolian population is nomadic.
Situated between China and Russia, Mongolia is one country
where vitamin D deficiency and rickets are major public health
problems, evident in the fact that one in four preschool children
has rickets. “Rickets is just the tip of the iceberg,” says Dr. Janet
Rich-Edwards, who is director of Developmental Epidemiology
at the Connors Center for Women’s Health and Gender Biology at
BWH. ”Where you have prevalent rickets, you are likely to have
a host of infectious and chronic diseases linked to lack of vitamin D. In school-age children, you might see increased respiratory infection, skin conditions and faltering growth in the winter,
when vitamin D levels are low.”
Dr. Rich-Edwards and her colleagues who make up the Blue Sky
Team - in reference to Mongolia’s nickname, “The Land of the Blue
Sky” - have spent the last year studying how Mongolian children
can improve their vitamin D intake with the goal of helping develop and implement a National Action Plan to ensure adequate
vitamin D levels among the country’s 2.8 million people. Specifically, the team’s research addressed whether fortified milk was
as effective as vitamin D supplements, (Mongolia cont. on back)
www.brighamandwomens.org/research/
Mongolia (cont.)
and whether daily vitamin D intake was superior to a one-time administration of a large
vitamin D dose thought to last the winter.
An annual supplement would be considerably easier to administer on a population
level than daily supplements.
To answer these questions, the Blue Sky Team
– which includes Dr. Ganmaa Davaasambuu,
of Harvard School of Public Health, and Dr.
Lindsay Frazier, of Dana-Farber Cancer Institute – studied 750 school-age children in
Mongolia’s capital city of Ulaanbaatar, where
they worked with a local producer to fortify Mongolian milk with vitamin D. Over
the course of the winter, the school children
consumed the standard unfortified milk, the
new fortified milk, daily vitamin D supple-
ments, or a large dose of vitamin D delivered
as a single dose at the beginning of the study.
Since the fortified milk and supplement regimens each delivered the same total amount
of vitamin D over the winter – approximately
300 IU per day – their effectiveness could be
directly compared.
In January, 98 percent of the children had
deficient vitamin D levels. After six weeks of
intervention, that figure had dropped to 44
percent among the children who received
daily supplements or fortified milk, which
were equally effective. In contrast, 98 percent
of the children who received the single large
dose were again deficient within six weeks,
as were 99 percent of the children who drank
the typical unfortified milk. The investigators
Research Literacy
Vitamin D: its main function in the body is to maintain normal
blood levels of calcium and phosphorus; is known as the “sunshine
vitamin” because the body manufactures the vitamin after being exposed to sunshine.
Vitamin D deficiency: can occur when usual intake is lower than
recommended levels over time, exposure to sunlight is limited, the
kidneys cannot convert vitamin D to its active form, or absorption of
vitamin D from the digestive tract is inadequate.
Clinical trial: a type of research study that tests how new medical
approaches work in people; tests new methods of screening, prevention, diagnosis, or treatment of a disease or condition.
Treatment group: a group of people recruited to participate in a clinical trial who receive the active treatment; this group is monitored
for effects related to the treatment.
Control group: a group of people recruited to participate in a clinical
trial who receive a non-active form of the treatment (a placebo); this
group is monitored for effects that arise at random or from expectations
concerning the treatment, rather than from the treatment itself.
Be a part of Discoveries in the Making
Predictive, proactive, preventive: the Biomedical Research Institute’s (BRI) vision for healthcare. Using our burgeoning knowledge of the genome, our vast resources from tissue banks, and
the brightest minds in healthcare, the BRI approaches disease
where it starts: at the cellular and molecular level. It is our hope that
someday this approach will allow us to personalize treatment that can
halt disease processes before they occur.
You can play a part in fueling the BRI’s groundbreaking studies.
Consider supporting the BRIght Futures Fund, a new way to seed and
support biomedical research and the creative, passionate people who
have made the life sciences their life’s work. Contact BRI Development
Director Nan Doyle at [email protected] or 617-424-4307, or visit
www.brighamandwomens.org/research/.
concluded that daily intake of at least 400 IU
would be necessary to eliminate deficiency.
The Blue Sky Team is now working with
the Mongolian government and private sector to determine the best mode of delivering
fortified foods. In a country where nearly 50
percent of the population is nomadic herders who rely on their own animals for milk,
a strategy to fortify flour with vitamin D
instead of milk might be more effective at
reaching the whole population. Dr. Rich-Edwards and her colleagues hope to move forward and work with a group of stakeholders
in Mongolia to draft a strategy for improving
vitamin D intake for not just a few hundred
school children, but for all of the country’s urban and rural people.
VitD: From Research to Therapy
For certain populations, such as people who have had hip
fractures, high doses of vitamin D are already being used as a
therapy. Research conducted by Dr. Meryl LeBoff and Dr. Julie
Glowacki found that 90 percent of patients who had a hip fracture also had insufficient levels of vitamin D. Further studies
showed that hip fracture patients with low levels of vitamin D
suffered from more falls and reduced lower extremity physical
performance than patients with higher levels of the vitamin one
year following their original injury, says Dr. LeBoff, who is the
founder and director of BWH’s Skeletal Health and Osteoporosis
Center and Bone Density Unit.
With the help of their colleague Dr. Mitchel Harris, Dr. LeBoff
and Dr. Glowacki instituted a program that measures vitamin D
levels of hip fracture patients admitted to BWH and places them
on a 50,000 IU dose of the vitamin until doctors can restore their
levels closer to normal. From then on, the patients’ vitamin D levels need to be checked and maintained as treatment for osteoporosis is instituted.
They are continuing their bench-to-bedside research – which is
unique because it uses human marrow that would have been discarded following orthopedic surgeries – and working on ways to
help patients post-operatively. “It’s been transforming hip fracture care at Brigham and Women’s Hospital,” LeBoff says.
This research is evolving, but despite the unfulfilled expectations of studies on the medical benefits of other vitamins, many
investigators are encouraged by the positive results observed
thus far in studies on vitamin D. If clinical trials prove high doses
of vitamin D are beneficial, intervention could be inexpensive.
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